Bipolar Disorder

• FDA approval · 2012-03-20
  FDA Approved: OLANZAPINE — Supplemental Application (American Regent, Inc.)

  FDA approved a supplemental application for olanzapine from American Regent, Inc., for this generic product.

• FDA approval · 2012-03-20
  FDA Approved: OLANZAPINE — Original Application (American Regent, Inc.)

  FDA approves American Regent's original-application generic olanzapine product (olanzapine) for distribution in the United States.

• FDA approval · 2012-03-15
  FDA Approved: LAMOTRIGINE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  The FDA approved a supplemental application for lamotrigine from Dr. Reddy's Laboratories Limited. The approval concerns the generic lamotri…

• FDA approval · 2012-03-15
  FDA Approved: LAMOTRIGINE — Supplemental Application (Alembic Pharmaceuticals Limited)

  The FDA approved a supplemental application for Lamotrigine from Alembic Pharmaceuticals Limited, sanctioning an updated approval for the ge…

• FDA approval · 2012-03-15
  FDA Approved: DIVALPROEX SODIUM — Original Application (Dr. Reddy's Laboratories Ltd)

  The FDA approved Dr. Reddy's Laboratories' original application for divalproex sodium, a generic anticonvulsant, for use in conditions such …

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• FDA approval · 2012-03-14
  FDA Approved: LAMOTRIGINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for Lamotrigine from Sun Pharmaceutical Industries, Inc. The action indicates a labeling update or p…

• FDA approval · 2012-03-12
  FDA Approved: RISPERIDONE — Supplemental Application (Janssen Pharmaceutical, Inc.)

  FDA approved a supplemental application for risperidone (Risperidone) by Janssen Pharmaceutical, Inc. The approval signals changes or additi…

• FDA approval · 2012-03-06
  FDA Approved: LITHIUM CARBONATE LITHIUM CARBONATE — Supplemental Application (Alembic Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Alembic Pharmaceuticals to market a generic lithium carbonate product.

• FDA approval · 2012-03-06
  FDA Approved: LITHIUM CARBONATE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark Pharmaceuticals' supplemental application for lithium carbonate, updating the existing product approval. The snippet d…

• FDA approval · 2012-03-06
  FDA Approved: LITHIUM CARBONATE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved a supplemental application for lithium carbonate submitted by Camber Pharmaceuticals, Inc.

• FDA approval · 2012-03-06
  FDA Approved: LITHIUM CARBONATE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved a supplemental application for lithium carbonate filed by Glenmark Pharmaceuticals Inc., USA.

• FDA approval · 2012-03-06
  FDA Approved: LITHIUM CARBONATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Lithium Carbonate submitted by Hikma Pharmaceuticals USA Inc.

• FDA approval · 2012-03-02
  FDA Approved: ZIPRASIDONE HYDROCHLORIDE — Original Application (Apotex Corp.)

  FDA approved Apotex Corp.'s original application for a generic ziprasidone hydrochloride product, enabling a generic version of this antipsy…

• FDA approval · 2012-03-02
  FDA Approved: ZIPRASIDONE — Original Application (Dr. Reddy's Laboratories Limited)

  The FDA approved Dr. Reddy's Laboratories Limited's generic Ziprasidone as an original ANDA, enabling a generic version of the antipsychotic…

• FDA approval · 2012-03-01
  FDA Approved: RISPERIDONE — Supplemental Application (Westminster Pharmaceuticals, LLC)

  The FDA granted Westminster Pharmaceuticals, LLC a supplemental approval for risperidone, updating the approved product's labeling.

• FDA approval · 2012-02-27
  FDA Approved: LAMOTRIGINE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for lamotrigine from Zydus Pharmaceuticals USA Inc.

• FDA approval · 2012-02-21
  FDA Approved: RISPERIDONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for risperidone from Sun Pharmaceutical Industries, Inc. under an Abbreviated New Drug Application, …

• FDA approval · 2012-01-31
  FDA Approved: LAMOTRIGINE KIT — Supplemental Application (OWP Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Lamotrigine Kit from OWP Pharmaceuticals, expanding the lamotrigine product offering. The approv…

• FDA approval · 2012-01-30
  FDA Approved: RISPERIDONE — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application for a generic risperidone product from Amneal Pharmaceuticals LLC. Risperidone is an antipsychot…

• FDA approval · 2012-01-30
  FDA Approved: OLANZAPINE — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's generic olanzapine under an Original Application, establishing a generic version of the antipsychotic for schizophrenia …

• FDA approval · 2012-01-30
  FDA Approved: RISPERIDONE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for a generic risperidone from Aurobindo Pharma Limited, granting approval for a generic version of …

• FDA approval · 2012-01-27
  FDA Approved: EQUETRO — Supplemental Application (Validus Pharmaceuticals LLC)

  The FDA approved a supplemental application for EQUETRO (carbamazepine) submitted by Validus Pharmaceuticals LLC.

• FDA approval · 2012-01-27
  FDA Approved: LITHIUM CARBONATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Lithium Carbonate from Hikma Pharmaceuticals USA Inc., resulting in an approved change to the ex…

• FDA approval · 2012-01-26
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for the generic anticonvulsant carbamazepine from Chartwell RX, LLC.

• FDA approval · 2012-01-24
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for carbamazepine submitted by Sun Pharmaceutical Industries, Inc.